PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Trial Parameters
Brief Summary
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety. The VERTICALE® Cervical System is intended for immobilization and stabilization of spinal segments of the craniocervical junction (occipital-C2), subaxial cervical spine (C3-C7) and upper thoracic spine (T1-T3). Primary Objective: To assess the functional outcome and clinical benefit of the VERTICALE® Cervical System for the patient using the NDI (Neck Disability Index) questionnaire. Primary endpoint hypothesis: The investigators hypothesize that NDI improves by at least 10% or 5 points at 12 months FU (Follow-Up) compared with preoperatively.
Eligibility Criteria
Inclusion Criteria: Ability to read, understand and speak the local language fluently to ensure understanding of Informed consent and protocol specific investigations * The surgical indication must be one or a combination of the following * Degenerative disc disease (DDD) * Instabilities * Trauma * Deformities * Mono-, bi- and multisegmental restoration (occipital T3) * Age: ≥ 18 years * The subject must give written informed consent before inclusion into the PMCF study. Exclusion Criteria: Relative and absolute contraindications according to IFU (Instruction for Use): Under certain circumstances, implantation is prohibited or associated with substantial risks, even though there may be an indication for it. These include in particular: * Anticipated or documented allergy or intolerance to the materials (e.g., titanium or cobalt chromium). * Active systemic infection or an infection localized to the site of the proposed implantation * Any case in which the chosen implants would be too l